ZUTR30005KITS

GUDID 00724995360238

Endo Leak Kit contains Endo Leak Tester, Storz Adapter, Calibration Adapter, Calibration Gauge, and power supply.

MEDIVATORS INC.

Invasive medical device leak tester, electrical
Primary Device ID00724995360238
NIH Device Record Keyd5705fce-0e10-4c41-8f1c-817c2b719efa
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberEndo Leak Tester Kit-4010828
Catalog NumberZUTR30005KITS
Company DUNS068199363
Company NameMEDIVATORS INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995360238 [Primary]

FDA Product Code

FCYBulb, inflation, for endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-12
Device Publish Date2026-02-04

Devices Manufactured by MEDIVATORS INC.

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